Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Phase 2

Completed

• Conditions: Non-Hodgkins Lymphoma

• Registration Number: NCT00193505
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Detailed Description

Upon determination of eligibility, patients will receive:

* Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
• Persistent lymphoma after one or two previous chemotherapy regimens
• Patients should not be considered candidates for high-dose chemotherapy
• Ability to perform activities of daily living with assistance
• Measurable or evaluable disease
• Age > 18 years
• Adequate bone marrow, liver and kidney function

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Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Patients with impaired bone marrow reserve
• Female patients who are pregnant or lactating
• Serious active infection at the time of treatment
• Any other serious underlying condition
• Brain or meningeal) with lymphoma
• HIV or AIDS-related lymphoma
• Received external beam radiation therapy to > 25% of active bone marrow.
• History of other cancers, either active or treated

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete response rate

Secondary Outcome Measures

Name	Time	Method
progression-free survival
overall survival

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States